Trial Outcomes & Findings for Ice Immersion Using Virtual Reality & Augmented Reality (NCT NCT04196686)
NCT ID: NCT04196686
Last Updated: 2022-03-25
Results Overview
Given that the cold pressor test produces an uncomfortable experience, we considered longer duration within the ice bath to represent increased pain tolerance. Measured in seconds (s).
COMPLETED
NA
185 participants
Duration of ice bath (approximately 0 - 4 minutes)
2022-03-25
Participant Flow
185 participants signed informed consent, 156 participants were allocated to a study arm
Participant milestones
| Measure |
Ice Bath Control Then VR/AR
Participants placed their dominant or non-dominant hand in ice bath without the use of Virtual Reality (VR)/Augmented Reality (AR), then crossed to place their opposite hand in ice bath with the use of VR/AR
|
Ice Bath With VR/AR Then Control
Participants placed their dominant or non-dominant hand in ice bath with the use of Virtual Reality (VR)/Augmented Reality (AR), then crossed to place their opposite hand in ice bath without the use of VR/AR
|
|---|---|---|
|
First Treatment (4 Minutes)
STARTED
|
78
|
78
|
|
First Treatment (4 Minutes)
COMPLETED
|
78
|
75
|
|
First Treatment (4 Minutes)
NOT COMPLETED
|
0
|
3
|
|
Second Treatment (4 Minutes)
STARTED
|
78
|
75
|
|
Second Treatment (4 Minutes)
COMPLETED
|
78
|
75
|
|
Second Treatment (4 Minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ice Bath Control Then VR/AR
Participants placed their dominant or non-dominant hand in ice bath without the use of Virtual Reality (VR)/Augmented Reality (AR), then crossed to place their opposite hand in ice bath with the use of VR/AR
|
Ice Bath With VR/AR Then Control
Participants placed their dominant or non-dominant hand in ice bath with the use of Virtual Reality (VR)/Augmented Reality (AR), then crossed to place their opposite hand in ice bath without the use of VR/AR
|
|---|---|---|
|
First Treatment (4 Minutes)
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Ice Immersion Using Virtual Reality & Augmented Reality
Baseline characteristics by cohort
| Measure |
All Participants
n=153 Participants
Participants placed their dominant or non-dominant hand in ice bath with or without the use of VR/AR, then crossed to place their opposite hand in ice bath using the opposite treatment or control
|
|---|---|
|
Age, Continuous
|
29.10 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
153 Participants
n=5 Participants
|
|
First hand assignment
Dominant
|
73 Participants
n=5 Participants
|
|
First hand assignment
Non-Dominant
|
80 Participants
n=5 Participants
|
|
VR hand assignment
Dominant
|
83 Participants
n=5 Participants
|
|
VR hand assignment
Non-Dominant
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of ice bath (approximately 0 - 4 minutes)Population: Participants who complete the respective interventions are included in the analysis.
Given that the cold pressor test produces an uncomfortable experience, we considered longer duration within the ice bath to represent increased pain tolerance. Measured in seconds (s).
Outcome measures
| Measure |
Ice Bath Control
n=156 Participants
Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR
|
Ice Bath With VR/AR
n=153 Participants
Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
|
|---|---|---|
|
VR Effect on Pain Tolerence
|
135 seconds
Standard Deviation 92
|
158 seconds
Standard Deviation 89
|
SECONDARY outcome
Timeframe: Duration of ice bath (approximately 0 - 4 minutes)Population: Participants who complete the respective interventions are included in the analysis.
During ice bath data collection participants will be asked to report pain on a numeric rating scale from 0-10, 0 being no pain and 10 being most excruciating pain imaginable every 30 seconds during ice bath
Outcome measures
| Measure |
Ice Bath Control
n=156 Participants
Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR
|
Ice Bath With VR/AR
n=153 Participants
Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
|
|---|---|---|
|
VR's Effect on Perceived Pain Intensity
150 seconds
|
5.9 score on a scale
Standard Deviation 2.0
|
5.5 score on a scale
Standard Deviation 2.3
|
|
VR's Effect on Perceived Pain Intensity
0 seconds
|
2.1 score on a scale
Standard Deviation 1.3
|
2.0 score on a scale
Standard Deviation 1.3
|
|
VR's Effect on Perceived Pain Intensity
30 seconds
|
4.9 score on a scale
Standard Deviation 2.1
|
4.4 score on a scale
Standard Deviation 2.1
|
|
VR's Effect on Perceived Pain Intensity
60 seconds
|
6.0 score on a scale
Standard Deviation 1.9
|
5.5 score on a scale
Standard Deviation 2.0
|
|
VR's Effect on Perceived Pain Intensity
90 seconds
|
6.2 score on a scale
Standard Deviation 2.0
|
5.9 score on a scale
Standard Deviation 2.1
|
|
VR's Effect on Perceived Pain Intensity
120 seconds
|
6.0 score on a scale
Standard Deviation 2.0
|
5.7 score on a scale
Standard Deviation 2.0
|
|
VR's Effect on Perceived Pain Intensity
180 seconds
|
5.6 score on a scale
Standard Deviation 2.1
|
5.3 score on a scale
Standard Deviation 2.4
|
|
VR's Effect on Perceived Pain Intensity
210 seconds
|
5.5 score on a scale
Standard Deviation 2.3
|
5.1 score on a scale
Standard Deviation 2.5
|
|
VR's Effect on Perceived Pain Intensity
240 seconds
|
5.2 score on a scale
Standard Deviation 2.3
|
5.0 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Duration of ice bath (approximately 0 - 4 minutes)Population: Participants who complete the respective interventions are included in the analysis.
The effects of VR on modulating sympathetic response in the presence of painful stimuli, was assessed by analyzing SCRD per 30 second interval. We refer to each of these 30 second intervals as a separate epoch. Skin conductance is expected to increase with increasing sympathetic nervous system activity, as sympathetic activity increases sweat secretion to increase skin conductance.
Outcome measures
| Measure |
Ice Bath Control
n=156 Participants
Participants placed their dominant or non-dominant hand in ice bath without the use of VR/AR
|
Ice Bath With VR/AR
n=153 Participants
Participants placed their dominant or non-dominant hand in ice bath with the use of VR/AR
|
|---|---|---|
|
Skin Conductance Response Density (SCRD)
|
0.10 microsiemens
Standard Deviation 0.069
|
0.09 microsiemens
Standard Deviation 0.061
|
Adverse Events
Ice Bath Control
Ice Bath With VR/AR
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Samuel Rodriguez, MD
Lucile Packard Children's Hospital Stanford
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place